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The effect of post-operative infusion of ultra-low dose of naloxone on post hystrectomy morphine consumption, side effects and pain intensity

Protocol summary

Summary
In this prospective, randomized, double-blind study, we evaluated the effect of an ultra-low dose of naloxone infusion on the amount of postoperative morphine consumption and the reduction of opioid induced side effects post- operative nausea and vomiting(PONV) and pruritus. Ninety patients scheduled for total abdominal hysterectomy and classified as American Society of Anesthesiologists physical status 1 or 2 were enrolled in the study. They were randomized to either saline (control, n=45) or naloxone 0.2µg.kg-1.h-1(n=45) for 24 hours. Standardized general anesthetics were administered in both groups. In the Recovery room, patients received morphine by patient-controlled analgesia. Ultra- low dose naloxone was infused intravenously at 0.2µg.kg-1.h-1 for 24 hours, in the intervention group and saline in control group. Morphine use, numeric rating score (NRS) for pain intensity, nausea, vomiting, pruritus, and requests for antiemetic were recorded at baseline , 30min and every 4 hour up to 24 hours after surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012025175N4
Registration date: 2011-02-10, 1389/11/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-02-10, 1389/11/21
Registrant information
Name
Ali Movafegh
Name of organization / entity
Dr. Shariati Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2373
Email address
movafegh@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
private
Expected recruitment start date
2010-12-02, 1389/09/11
Expected recruitment end date
2011-06-06, 1390/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of post-operative infusion of ultra-low dose of naloxone on post hystrectomy morphine consumption, side effects and pain intensity
Public title
Effects of Naloxane on Pain Control in Post operative Management of Hysterectomy Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1-ASA physical status I and II scheduled for total abdominal hysterectomy with standadized general aneshteshia/ 2-Age between 35-65 years old Exclusion criteria : 1-Hepatic or Renal failure, Heart diseases, 2- history of drug allergy, substance abuse (including opioids and benzodiazepines) , 3-morbid obesity, 4-history of postoperative nausea and vomiting(PONV),history of motion sickness 5- smokers
Age
From 35 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Medicine
Street address
Faculty of Medicine, Tehran University of Medical Sciences and Health Care
City
Tehran
Postal code
Approval date
2010-12-03, 1389/09/12
Ethics committee reference number
374/1892

Health conditions studied

1

Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
acute pain

Primary outcomes

1

Description
Morphine Consumption
Timepoint
0 ,30 min,1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr after surgery
Method of measurement
Opioid registration by milligrams

2

Description
Pain Intensity
Timepoint
0 ,30 min,1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr after surgery
Method of measurement
NRS( Numeric Rating Score)

Secondary outcomes

1

Description
duration of operation
Timepoint
during the operation
Method of measurement
operating chart

2

Description
Intraoperative Fluid received
Timepoint
during the operation
Method of measurement
Crystaloid Fluid registration chart

3

Description
Pruritus
Timepoint
0 ,30 min,1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr after surgery
Method of measurement
Numeric Rating score (NRS)

4

Description
Post operative Nausea and Vomiting
Timepoint
0 ,30 min,1hr, 2hr, 4hr, 8hr, 16hr, 20hr, 24hr after surgery
Method of measurement
NRS (Numeric Rating score)

Intervention groups

1

Description
Intervention: (Naloxone Group n=45 ) Before surgery, patients in group N received a loading dose of Naloxone (1ng. kg-1) then In the recovery room, patients were attached to a a patient controlled analgesia (PCA) device. The PCA device was programmed to achieve patient’s comfort by delivery on demand. The device contained 30 mg Morphine in 30 ml saline 9% (1mg/ml). After a loading dose of intravenous Morphine 40µg/kg ,a bolus dose of 1mg Morphine was administered with lockout interval of 8 min with no preset of maximum dose.
Category
Treatment - Drugs

2

Description
Control group (n=45): Before the surgery, patients in this group received Saline, in 2 mL then in the recovery room, patients were attached to a patient controlled analgesia (PCA) device. The PCA device was programmed to achieve patient’s comfort by delivery on demand. The device contained 30 mg Morphine in 30 ml saline 9% (1mg/ml). After a loading dose of intravenous Morphine 40µg/kg, a bolus dose of 1mg Morphine was administered with lockout interval of 8 min with no preset of maximum dose.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Ali Shariati Hospital
Full name of responsible person
Dr.Ali Movafegh
Street address
Shariati Hosp, North Karegar Ave,
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences and Health Services
Full name of responsible person
Shahin Akhoundzade
Street address
Tehran University of Medical Sciences, Vice Chancellor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Department of Anesthesiology,Tehran University of medical sciences
Full name of responsible person
Dr Ali Movafegh
Position
Assocciate Prof.
Other areas of specialty/work
Street address
Dr.Ali Shariati Hospital,North Karegar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Ali Movafegh
Position
Assoc. Prof
Other areas of specialty/work
Street address
Dr.Ali Shariati Hosp,North Karegar St.
City
Tehran
Postal code
1411713135
Phone
+98 21 8490 2372
Fax
Email
movafegh@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Anesthesiology Dep, Tehran University of Medical Sciences
Full name of responsible person
Mitra Ansari
Position
Other areas of specialty/work
Street address
DR.Ali Shariati Hosp,North Karegar St.
City
Postal code
1411713135
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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